510(k) · Cleared
Recalled · Class II · 2015Gemini Pet/CT Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · KPS System, Tomography, Computed, Emission
Cleared on Jul 29, 2004 as substantially equivalent to K032036 (Philips Medical Systems (Cleveland), Inc., 2003) and 3 other predicates after an 8-day review. Its family tree reaches back 5 generations to 1993. 65 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 29, 2004
- Review
- 8 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 5 generations to K930090 (1993). 17 ancestors in all. 65 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK930090 HelicatElscint, Inc. · 1993
- 4 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 3 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 2 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- This deviceK041955 Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004
- Descendant · cites it directly · 49 of its ownK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- Descendant · 2 generations on · 41 of its ownK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- Descendant · 3 generations on · 39 of its ownK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- Descendant · 4 generations on · 32 of its ownK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
- Descendant · 5 generations on · 28 of its ownK172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…Philips Health Care · 2017 · Recalled
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K062650EP Navigator SoftwarePhilips Medical Systems · 2006 · cites it directly49descendants
- K101311EP Navigator R3Philips Medical Systems North America Co. · 2010 · 2 generations on41descendants
- K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011 · 3 generations on39descendants
- K121781Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012 · 4 generations on32descendants
- K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care · 2017 · 5 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −4 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −3 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −2 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −1 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| 0 (this device) | K041955 | Gemini Pet/CT Imaging System | Philips Medical Systems (Cleveland), Inc. | 2004 | — |
| +1 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| +2 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| +3 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
| +4 | K121781 | Echonavigator Release 1 | Philips Medical Systems Nederland B.V. | 2012 | — |
| +5 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound… | Philips Health Care | 2017 | 31 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 10 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032036 | Gemini 16Summary page 1…21 CFR 892.1750, Class 11 Product Code: 90 KPS and 90 JAK C. Date prepared: June 18, 2004 D. Predicate Device: Gemini 16 (K032036) Mx8000 IDT CT System (K012009) Allegro Imaging System (K033782)… | 2003 |
| * | K012009 | MX8000 Idt CT SystemSummary page 1…90 KPS and 90 JAK C. Date prepared: June 18, 2004 D. Predicate Device: Gemini 16 (K032036) Mx8000 IDT CT System (K012009) Allegro Imaging System (K033782) Discovery LS System (K040172) E. P… | 2001 |
| * | K033782 | Allegro Imaging SystemSummary page 1…D. Predicate Device: Gemini 16 (K032036) Mx8000 IDT CT System (K012009) Allegro Imaging System (K033782) Discovery LS System (K040172) E. Performance Standards: * 21 CFR 1020.30 - 1020.33 Perfo… | 2003 |
| * | K040172 | Modification to GE Discovery LS SystemSummary page 1…Mx8000 IDT CT System (K012009) Allegro Imaging System (K033782) Discovery LS System (K040172) E. Performance Standards: * 21 CFR 1020.30 - 1020.33 Perfornmance Standards for Ionizing Radiation Emitting P… | 2004 |
What descends from it? (65)
See all 652 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2015 | Class II | Z-1776-2015 | Nonconforming Material/Component | The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes. |
| Nov 6, 2006 | Not classified | Z-0013-2007 | Other | A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 8 of the 17 ancestors have a recall of any class.
- Of its descendants, K062650 (Philips Medical Systems, 2006) has gone furthest, with 49 descendants of its own.
- 1 other device also cites its predicate K032036.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, head, heart and…
Read the full statement (265 words)
The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, head, heart and other organ imaging). Attenuation correction is accomplished by either CTAC or Cs-137. The device also provides for list mode, dynamic, and gated acquisitions.
Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:
o The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders.
o The detection, localization, and staging of tumors and diagnosing cancer patients.
o Treatment planning and interventional radiology procedures.
Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.
Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041955 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041955: Gemini Pet/CT Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041955
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026